Davita First Colony Dialysis Center

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 22676 Based on observation, interview, facility policy review and review of Centers for Disease Control (CDC) guidance, the facility failed to ensure that the 13 out of 16 wall boxes (dispensing outlets) at dialysis stations and 10 out of 12 dialysis machines was cleaned and the buildup of white crystals and yellow substance removed. This deficient practice had the potential to cause bacteria to grow in the wall boxes and cause harm by infecting the 70 patients receiving in-center hemodialysis at the facility. Findings included: Observation of the wall boxes on 01/25/24 at 10:30 AM, at each dialysis station, stations numbered 1, 3, 6, 7, 9, 10, 11, 10, 11 and 12 revealed a dark yellow sediment with white sediment build-up on the wall boxes. During an interview on 01/25/24 at 10:30 AM, the Administrator 2 and Clinical Services Director 7, confirmed the wall boxes had a dark yellow with white crystal sediment build-up on the wall box. Review of facility’s policy titled, “Infection Control for Dialysis Facilities,” dated April 23, indicated, “ ...equipment including the dialysis delivery system ... wiped clean with bleach solution of the appropriate strength ...thought out the workday and after each treatment ...” Review of the “CDC Dialysis Safety” located on the CDC website at www.cdc.gov titled “Wall boxes and Drains” indicated, “All box surfaces should be disinfected at least daily (e.g., at the end of the day after all patients have dialyzed); cleaning and disinfection might be needed more frequently (e.g., when visibly dirty). Cleaning and disinfection of the wall box should be performed after the patient has left the station, and not during patient care activities ... More than one disinfectant wipe or application may be needed to ensure all wall box surfaces are visibly wet with disinfectant to achieve contact time specified by the manufacturer.””

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 22676 Based on observation, interview, and policy review, the facility failed to restrict access to the water purification and storage system to only individuals responsible for monitoring and maintenance of the system on one of three survey days. Failure to restrict access to the water purification and storage system to only individuals responsible for monitoring and maintenance of the system had the potential to negatively impact the safety and well-being of the 77 in-center dialysis patients receiving treatments at this facility. Findings include: During tour of the facility on 01/25/24 at 10:00 AM, observed the door leading to the water purification system and the bicarb and acid storage area was locked with a coded entry. The locked area contained two rooms. On entry the room was a large area. Observed a second door that was secured with the same code, which opened into a room that contained the water purification system. During an interview on 01/25/24 at 10:00 AM, Biomed 6 confirmed access to the water purification and storage system was not restricted to only authorized users who were responsible for the monitoring and maintaining the system. Biomed 6 stated that all areas within the building use the same code as the water area.” During an interview on 01/25/24 at 11:00 AM, Administrator 2 confirmed that all staff were given the code to all coded areas, and it was the same as the water room code and the other doors in the facility. Review of the facility’s policy titled, “Water Treatment System Minimum Component Requirement,” dated October 2021, indicated, “Access to the water treatment system should be restricted to those personnel/trained teammates responsible for monitoring, maintenance of the system and supply ordering.””

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 22676 Based on review of glucometer logs, interview, facility policy review, and review of manufacturer’s instructions, the facility failed to ensure the glucometers were in the control range and follow manufacturer’s instructions for one of one glucometer used in the facility. This had the potential to provide inaccurate glucose results that could result in mistreated blood glucose levels to all 70 patients receiving care at the facility. Findings include: Review of Blood Glucose logs provided by the facility Administrator, for Glucometer (EE19100789) from 11/01/23 through 01/21/24 revealed the acceptable low blood glucose control range should be 94-126. On 12/09/23, the recorded low control was 127. During an interview on 01/25/24 at 1:35 PM, with the Facility Administrator 2 and the Manager of Clinical Services 7, he/she confirmed the staff did not repeat calibration of the abnormal low testing level. Review of the facility’s policy titled, “Embrace PRO Blood Glucose Monitoring System Quality Control” dated September 2020, revealed, “. . . 16. If control results fall outside the acceptable range the test must be repeated.” Review of the “Embrace Pro” blood glucose monitoring system manufactures instruction revision date 09/2020 revealed, “ ...p. eleven, if the “test fall outside the range printed on the test strip vial, repeat the test ...””

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 22676 Based on record reviews, interview, and policy review, the facility failed to follow the individualized dialysis (an artificial means of kidney function that removes the waste and excess fluid from the blood by passing through a filter) prescription as determined by the medical provider for one of seven sampled in-center patients (Patient (P) 21). Failure to follow the medical providers’ dialysis prescription had the potential to negatively impact the effectiveness of the prescribed dialysis treatments for the all 70 patients receiving in-center dialysis treatments at this facility. Findings include: Review of 21’s electronic medical record (EMR) revealed a prescribed blood flow rate (BFR) 350 milliliters per min (ml/min). Review of one of six “Post Treatment” flowsheets from 01/06/24 through 01/23/24, in the EMR indicated the following: On 01/02/24, the BFR was documented at 300 ml/min from 5:45 AM until 8:30 PM. There was no documented rationale for the change to the prescribed BFR. During an interview on 01/26/24 at 2:30 PM, the Administrator 2 and Manager of Clinical Services 7 confirmed the above findings and confirmed that staff did not follow the facility’s policy. Review of the facility’s policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Assessment,” dated 10/23, revealed, “The Nursing assessment will be performed and documented ...Verification of the prescription including machine parameters ...””